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Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

Primary Purpose

Psoriasis Vulgaris

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Methotrexate
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Psoriasis Vulgaris, Methotrexate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed according to Classification criteria for Psoriasis vulgaris
  2. Patients aged 18 to 70 years (to the date of screening)
  3. Not treatment in the Topical corticosteroids, Biologicals agents or Tretinoin cream
  4. Phototherapy nearly one months before enrolled
  5. Total bilirubin < 1.5 x ULN, AST(SGOT)/ALT(SGPT) <2.5 x ULN, if not liver metastases < 5 x ULN, if known liver metastases, Creatinine clearance <1.5 x ULN
  6. Understanding the whole process of the study, voluntary participation and signed the informed consent

Exclusion Criteria:

  1. Pregnant women, ready to pregnant or lactating women
  2. Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
  3. Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers
  4. Patients with chronic diarrhea, or peptic ulcer nearly 1 year
  5. Patients suffering from malignant tumor
  6. Patients suffering from acute and chronic infectious diseases
  7. Mental disorders, history of alcohol abuse, drug or other substance abuse
  8. Other cases which researchers believe that can not enroll

Sites / Locations

  • Xiangya Hospital Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single-arm

Arm Description

intervention: open registry, non-randomized, single-arm trial.Methotrexate:2.5mg per piece, oral.

Outcomes

Primary Outcome Measures

disease control rate

Secondary Outcome Measures

Full Information

First Posted
March 17, 2016
Last Updated
March 21, 2016
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT02715947
Brief Title
Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate
Official Title
Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate the influence of genetic factors on the curative effect , to find the relationships between genetic variants and the response of Methotrexate to treatment of Psoriasis Vulgaris.
Detailed Description
Previous studies have indicated that the gene mutations of absorption distribution metabolism and drug target may affect the efficacy of Methotrexate in vivo.To investigate the influence of genetic factors on the curative effect , to find the relationships between genetic variants and the response of Methotrexate to treatment of Psoriasis Vulgaris.Investigators analyzed the various levels of genetic factors, including: 1.To analysis the key gene variants which associated with ADME(absorption, distribution, metabolism and excretion) affect the efficacy of Methotrexate; 2.Direct full genetic sequencing of MHC genes, to explore the genetic variations of efficacy and side effects; 3. Direct sequencing of all exons in the gene in the patients of the response of serious and effectively, to explores the rare genetic variation may cause deterioration of treatment by Methotrexate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
Keywords
Psoriasis Vulgaris, Methotrexate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single-arm
Arm Type
Experimental
Arm Description
intervention: open registry, non-randomized, single-arm trial.Methotrexate:2.5mg per piece, oral.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
Amethopterin
Intervention Description
During The first week: 7.5mg per week, oral; The second and third weeks: 10mg per week, oral; The fourth and fifth weeks: 12.5mg per week,oral; The sixth week:15mg per week, and maintain this dose, oral.
Primary Outcome Measure Information:
Title
disease control rate
Time Frame
8 weeks after the first treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed according to Classification criteria for Psoriasis vulgaris Patients aged 18 to 70 years (to the date of screening) Not treatment in the Topical corticosteroids, Biologicals agents or Tretinoin cream Phototherapy nearly one months before enrolled Total bilirubin < 1.5 x ULN, AST(SGOT)/ALT(SGPT) <2.5 x ULN, if not liver metastases < 5 x ULN, if known liver metastases, Creatinine clearance <1.5 x ULN Understanding the whole process of the study, voluntary participation and signed the informed consent Exclusion Criteria: Pregnant women, ready to pregnant or lactating women Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers Patients with chronic diarrhea, or peptic ulcer nearly 1 year Patients suffering from malignant tumor Patients suffering from acute and chronic infectious diseases Mental disorders, history of alcohol abuse, drug or other substance abuse Other cases which researchers believe that can not enroll
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yijing He, MD,PhD
Phone
+86-1587481262
Email
yijinghe@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Chen, MD
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yijing He, MD, PhD
Phone
+86-1587481262
Email
yijinghe@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

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